Medicament dispenser

ABSTRACT

Disclosed is a medicament dispenser having a base unit and a replaceable refill container. The base unit has one or more sensors for sensing one or more conditions of the medicament dispenser and a display for displaying indicia representing a state of the medicament dispenser. First indicia show the base unit and second indicia show the refill container. The display of at least one of said first and said second indicia is selectively controllable independently of the display of the other of said first and said second indicia in order to indicate said one or more sensed conditions of the medicament dispenser.

TECHNICAL FIELD

The present invention relates to a medicament dispenser for dispensingmedicament. The invention particularly, but not exclusively, relates toan inhalation device for use in dispensing medicament.

BACKGROUND TO THE INVENTION

The use of inhalation devices in the administration of medicaments, forexample in bronchodilation therapy is well known. Such devices generallycomprise a body or housing within which a medicament container islocated. Known inhalation devices include those in which the medicamentcontainer is a blister strip containing a number of discrete doses ofpowdered medicament. Such devices usually contain a mechanism foraccessing these doses, usually comprising either piercing means or meansto peel the lid sheet away from the base sheet. The powdered medicamentcan then be accessed and inhaled.

It would be desirable to provide a portable medicament dispenser (e.g.an inhalation device) which is refillable by insertion of a replacementcontainer containing a medicament. The container may then be replacedwhen the medicament content is empty, allowing the majority of thedispenser to be retained. This allows the retained part of the dispenserto be fitted with additional features such as an electronics subsystemwhich may not be cost effective on a completely disposable and portabledispenser.

It is a further object of the present invention that the refillcontainer may be easily removed and that a new refill container can beeasily inserted. It is also desirable that the operation of themedicament dispenser is clear and non-complex to a user and that anysteps involved in preparing the dispenser for use are minimised andsimplified.

SUMMARY OF THE INVENTION

According to one aspect of the present invention, there is provided amedicament dispenser comprising a base unit, the base unit being adaptedfor receiving a replaceable refill container and for sensing one or moreconditions of the medicament dispenser, said base unit comprisingdisplay means for displaying indicia representing a state of themedicament dispenser, wherein said display means are configured todisplay:

-   -   first indicia providing a graphical representation of the base        unit; and    -   second indicia providing a graphical representation of a refill        container,    -   wherein the display of at least one of said first and said        second indicia is selectively controllable independently of the        display of the other of said first and said second indicia in        order to indicate said one or more sensed conditions of the        medicament dispenser.

According to a further aspect of the invention, there is provided amedicament dispenser comprising a base unit, the base unit being adaptedfor receiving a replaceable refill container, said base unit comprisinga display for displaying indicia representing a state of the medicamentdispenser, wherein said display means are configured to display:

-   -   first indicia providing a graphical representation of a physical        appearance of at least part of the medicament dispenser; and    -   second indicia representing one or more sensed conditions of the        medicament dispenser,    -   wherein said medicament dispenser includes a mechanical priming        component for initiating the dispensing of medicament and said        second indicia comprise indicia representing actuation of the        mechanical priming component.

The present invention provides a medicament dispenser capable ofproviding clear and concise status indications to the user duringoperation of the device in response to sensed operating conditions.

Furthermore, the indications may be provided without the need fortextual output, thereby simplifying the display structure and making thedevice suitable for use by users having varying different mother tonguesand of varying ages.

Features and advantages of the present invention will become apparentfrom the following description of preferred embodiments of theinvention, given by way of example only, made with reference to theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a perspective view of a medicament dispenser according toan embodiment of the invention with the cassette removed from the holderand body,

FIG. 2 shows a perspective view of the medicament dispenser of FIG. 1with the cassette inserted into the holder and body in thenon-dispensing position;

FIGS. 3 a and 3 b show plan views of the medicament dispenser of FIGS. 1and 2 with the cassette in the dispensing position;

FIG. 4 is an exploded perspective view of a holder;

FIG. 5 is a perspective view of a refill cassette from below;

FIG. 6 shows a perspective view of a medicament carrier for use inaccord with the present invention;

FIGS. 7 a and 7 b show a schematic view of an internal mechanism of acassette in accordance with an embodiment of the present invention;

FIG. 8 is a schematic block diagram of an electronic subsystem of themedicament dispenser;

FIGS. 9, 18, 20, 21, 22 illustrate alternative screen displayconfigurations; and

FIGS. 10 to 17 illustrate various display states used to indicatedifferent sensed conditions of the medicament dispenser.

DETAILED DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a medicament dispenser in accordance with an embodiment ofthe present invention, in the form of a base unit comprising an outercover 10 and a holder 20, and a refill cassette 30. The holder 20includes an electronic display 22 and an associated button 24. Theholder 20 is shaped to fit inside cover 10 and is fixed to the body viaa bearing (not shown) about which it rotates coaxially. Stops (notshown) protrude from the holder 20 and prevent the holder 20 fromrotating more than about 180° relative to the cover 10. The stops alsoprovide two defined positions of the holder 20 within the cover 10. Oneposition is defined by a stop meeting with a part of the cover 10 andthe other position defined by the other stop meeting with another partof the cover 10 when the holder has been rotated relative to the body.An outer part of the holder is shaped in the form of a concave recess 26to provide a thumb or finger grip for the user of the device. The holder20 forms a recess into which the refill cassette 30 latches.

The refill cassette 30 comprises a shell containing the medicamentcarrier and a mechanism for opening the carrier for the medicament to beaccessed (see FIG. 7). The refill cassette 30 has a rear end 32 which isexposed by a cut-away portion of the holder 20 when the rest of thecassette 30 is contained within the holder 20 so as to allow thecassette to be manually gripped for removal from the holder 20.

The refill cassette 30 also has a mouthpiece 36 from which a userinhales medicament dispensed from the cassette 30.

FIG. 2 shows the medicament dispenser with the cassette 30 in place inthe holder 20 and with cover 10 in a non-dispensing position in whichthe rear end 32 of the cassette is exposed. The cassette 30 is fixed inplace by a spring-biased catch (not shown). When the cassette 30 is inthe position shown, relative to the holder 20, the cover 10 covers themouthpiece (not shown). The cover 10 also protects the thumbtab of anindexing lever (not shown) and this prevents accidental indexing of themedicament carrier when the medicament dispenser is not in use.

FIGS. 3 a and 3 b show the medicament dispenser of FIGS. 1 and 2 withthe cassette 30 in place in the holder 20 in a dispensing position. Theholder 20 has been rotated relative to the cover 10 so that a stop onthe holder 20 abuts the cover 10. It can be seen that the holder 20 hasa further cut away portion to expose the mouthpiece 36.

FIG. 3 a shows the thumbtab 28 of the indexing lever in a resetposition, ready for actuation. Actuation of the thumbtab 28 indexes themedicament carrier within the refill cassette 30, thereby exposing adose of medicament ready for inhalation through the mouthpiece 36. FIG.3 b shows the configuration of the dispenser after the thumbtab 28 hasbeen actuated. The thumbtab sits within the recess covered by thedispenser cover 10. Rotation of the holder 20 within the cover 10following actuation of the thumbtab 28 resets the thumbtab 28 to itsreset position shown in FIG. 3 a The display 22 shown in FIGS. 3 a and 3b includes a graphical representation of the medicament dispenser,including a base unit icon, a refill icon, a set of time elapsed indiciaand a set of dose count indicia, to be described in further detailbelow. Note that the indicia representing the medicament dispenserprovide a graphical representation of the external appearance of therefill cassette and holder together when attached. The representation isaligned with the actual holder, such that the orientation of themouthpiece of the graphical representation coincides with that of themouthpiece 36, thereby increasing understandability of the display.

FIG. 4 is a vertically exploded perspective view of elements of theholder 20. The holder 20 includes an upper shell 40, on which thedisplay 22 and the button 24 are rigidly mounted, and a base 42. Thebase 42 includes an arcuate channel 40 in which a corresponding arcuateelement 44 is mounted to provide coaxial movement of the thumbtab 28 ofindexing lever 45, whereby priming of the refill cassette 30 isachieved. When inserting a new refill cassette 30 in the holder 20, aratcheted gear 46, attached to its spindle inside the refill cassette30, moves along a linear groove, as represented by arrow 48, in theholder 20, towards a central axial location within which the lever 45acts on gear 46 to rotate the spindle in response to movement of thethumbtab 28. It can also be seen that the upper shell 40 includes acut-out portion 41 whereby mouthpiece 36 is exposed in the holder afterinsertion thereof.

FIG. 6 shows a medicament carrier 50 for use in an embodiment of theinvention. The medicament carrier comprises a peelable blister strip 52defining a plurality of pockets 54 each of which contains a dose ofmedicament which can be inhaled, in the form of powder.

The strip comprises a base sheet 56 in which blisters are formed todefine the pockets 54 and a lid sheet 58 which is hermetically sealed tothe base sheet except in the region of the blisters in such a mannerthat the lid sheet 58 and the base sheet 56 can be peeled apart. Thesheets 56, 58 are sealed to one another over their whole width exceptfor the leading end portions 57, 59.

The lid 58 and base 56 sheets are each preferably formed of aplastics/aluminium laminate and are preferably adhered to one another byheat sealing.

The strip 52 is shown as having elongate pockets 54 which runtransversely with respect to the length of the strip 52. This isconvenient in that it enables a large number of pockets 54 to beprovided in a given strip length. The strip 52 may, for example, beprovided with from fifty to one hundred pockets 54 but it will beunderstood that the strip 52 may have any suitable number of pockets 54.

FIGS. 7 a and 7 b schematically show an internal mechanism of a refillcassette 30 containing a medicament carrier in one embodiment of theinvention. FIG. 7 a shows the medicament carrier in the situation wherethe majority of the pockets are still filled with discrete doses ofmedicament in the form of dry powder. FIG. 7 b shows the situation wherethe majority of pockets are empty and most of the lid sheet 58 has beenremoved from the base sheet 56.

The internal mechanism comprises an index wheel 60 and a lid-windingwheel 70 for winding the used portion of the lid sheet 58. The indexwheel 60 has a plurality of recesses 62 a, 62 b extending parallel withthe axis of the wheel. The recesses 62 a, 62 b are spaced at a pitchwhich is equal to the distance between the centre lines of adjacentpockets 54 a, 54 b.

The cassette 30 also includes an area 80 for the medicament carrier tobe coiled in prior to use of the doses contained inside it and an area82 where the used base of the medicament carrier is collected. Area 82contains base winding wheel 86 on which the used portion of the basesheet is wound. Also included is a movable wall 84 to separate these twoareas to separate the two areas 80, 82. The movable wall 84 is pushedfrom the position shown in FIG. 5 a by the growing coil of collectedbase sheet to the position shown in FIG. 5 b, thereby adjusting the sizeof the areas respectively.

The spindle mechanism (not shown) is arranged to unidirectionally rotatethe index wheel 60 and the lid-winding wheel 70 in unison and basewinding wheel 86.

The lid winding wheel shown in FIGS. 7 a and 7 b takes the form of acollapsible wheel 70. The collapsible wheel 70 has a series of resilientarms 72 a, 72 b radiating from a central shaft 74, each at an angle to aradius. The leading end of the lid sheet 58 is looped over one of theseresilient arms 72 a and the lid sheet 58 is wound onto the collapsiblewheel 70 as it is peeled away from the base sheet 56. As more lid sheet58 is wound onto the collapsible wheel 70, the resilient arms 70 a, 70 bgradually flex inwardly, and the effect is to keep the external diameterof the reel of wound up lid sheet 58 substantially constant while theinternal diameter decreases. Guide portion 88 guides the lid sheet fromthe point at which it is separated from the base sheet to the lidwinding wheel.

In operation, the user moves the holder relative to the body to move thecassette into the dispensing position and then presses on the finger tabof the lever to cause it to move. This leads to rotation of the indexwheel which results in rotation of both the base winding wheel and thelid winding wheel, thus peeling the base sheet and lid sheet apart overa distance sufficient to expose a previously unopened pocket oppositethe end of the powder outlet. The patient can then inhale the powderedmedicament through the mouthpiece.

FIG. 8 is a schematic block diagram of the electronic subsystem of themedicament dispenser. The holder 20 includes an in-built control unit90, for example in the form of a microprocessor chip, including aninternal clock. Various sensors are electrically connected to thecontrol unit 90, including a battery power level sensor 92, which sensesthe remaining power level of a battery providing electrical power to themedicament dispenser, also housed in the holder 20. A cover open sensor94 senses movement of the cover relative to the holder from thenon-dispensing position, in which the cover covers the mouthpiece of thedispenser, to an open position in which medicament may be dispensed. Arefill attach sensor 96 is associated with the mechanical connectionmechanism whereby a refill cassette is attached to a holder. When arefill is correctly attached, refill attach sensor 96 detects thecorrect attachment. When a refill is not attached, this can also besensed using refill attach sensor 96. A button switch 98 sensesactuation of the button 24. A priming reset sensor 100 senses theposition of the index lever in its reset position, whereas a primingactuation sensor 102 senses the position of the index lever in its fullyactuated position. Together sensors 100 and 102 are used to detectmovement of the index lever from its reset position to the actuatedposition to indicate the presentation of a new dose of medicament withinthe refill, which the user may take by inhaling through the mouthpiece.A radiation emitter 104 emits radiation into the mouthpiece, whilst aninhalation sensor 106 detects the emitted radiation on the other side ofthe mouthpiece. Together, the radiation emitter 104 and 106 are used toindicate the inhalation of a dose by the user. When the user inhales,the medicament powder causing scattering of the radiation emitted byradiation emitter 104, thereby reducing the detected level of radiationat inhalation sensor 106, indicating the inhalation of a dose.

The refill cassette 30 includes a memory chip 108, which is in datacommunication with the control unit 90 via a data communicationinterface 110. The data communication interface uses a transceiver inthe control unit 90 and a transceiver in the memory chip 108, whichcommunicate via electrical connections made when the refill cassette 30is inserted within the holder 20. Alternatively, the memory chip 108 maybe in the form of a radio frequency (RFID) tag, and the datacommunications interface 110 may be a wireless data communicationsinterface. Finally, the control unit 90 is operatively connected to thedisplay 22, for controlling the display in accordance with sensedconditions of the medicament dispenser.

Various different conditions of the medicament dispenser may be sensedby means of the electronic subsystem illustrated in FIG. 8. These are asfollows:

1. A refill attached condition, sensed by refill attached sensor 96.

2. A refill not attached condition, sensed by refill attached sensor 96.

3. A refill authenticated condition. When a refill cassette 30 isattached to the holder 20, the control unit 90 reads data from thememory chip 108. The data includes a current dose count for the refillcassette, and authentication data, such as a unique ID and an associateddigital signature. The control unit 90 stores an authenticationalgorithm, whereby the data read from the memory chip 108 may beauthenticated. If authenticated, the refill authenticator condition ishence sensed.

4. A refill invalid condition. If the authentication process carried outby the control unit when the refill is attached fails to authenticatethe refill cassette 30, the refill invalid condition is generated.

5. A dose count condition. The dose count read from the memory chip 108.When a dose is dispensed from the refill cassette 30, the control unit90 updates the current dose count on the memory chip 108 by decrementingthe current dose count. Thus, the dose count condition indicates asensed number of doses in the refill cassette 30.

6. A low dose remaining condition. When the number of doses within therefill cassette 30 falls below a preset threshold, the low doseremaining condition is generated.

7. A no dose remaining condition, at which point the refill cassette 30should be removed and a new refill cassette should be inserted.

8. A dose not due condition. After a dose is dispensed and/or inhaled,the control unit 90 begins a time elapsed function, which monitors atime elapsed since a dose was sensed to have been taken. The controlunit 90 uses a timing regimen, which may be preset in the control unit90 or read from the memory chip 108, to determine the length of timebetween dose reminders. For example, the timing regimen may operate on a12 hour interval, in which case a dose is ideally taken at 12 hourintervals. If the current time elapsed since the last taking of the doseis within the interval, the medicament dispenser is sensed to be withina dose not due condition.

9. A dose due condition. If the current time elapsed since the taking ofthe last dose is greater than the dose reminder interval, a dose duecondition is generated by the control unit 90.

10. A dose primed condition. Using priming reset and actuation sensors100, 102, the control unit 90 senses when a dose has been primed withinthe refill cassette 30, to generate the dose primed condition.

11. A dose inhaled condition. The control unit 90 uses radiation emitter104 and inhalation sensor 106 to detect inhalation of a primed dose. Oninhalation, the dose inhaled condition is generated.

12. A low battery level condition, as sensed by battery power levelsensor 92.

Each of FIGS. 9, 18, 19, 20, 21 and 22 show alternative embodiments 22a-f of screen layout for the display 22, whereby the various sensedconditions may be indicated to the user. Note that although notillustrated in FIG. 8, the electronic subsystem may also include otherforms of indicators, such as an audible alarm generator, which may beused, alone or in combination with visual display on the display, toindicate the generation of a new sensed condition in the medicamentdispenser. For example, when a dose due condition is generated, themedicament dispenser may indicate the sensed condition on the display,and also provide an audible alarm at intervals which increase infrequency and/or volume whilst the dose due condition remains. Each ofthe display configurations 22 a, 22 b, 22 c, 22 d, 22 e, 22 f aregenerated on a segmented LCD display. In a segmented LCD display, thedisplay indicia are formed by means of individual liquid crystalelements which are preconfigured in the display screen, and which may beseparately activated under the control of the control unit 90. Anadvantage of using a segmented display is increased clarity, along withreduced cost. However, other forms of display means may also be used,such as a pixellated LCD display, whereby indicia are formed usingcombined actuation of sets of pixels within the display. The display maybe monochrome or colour. Again, for increased clarity and reduced cost,a monochrome display is preferred. Some indicia on the display may bestatic indicia. For example, where the display shows a graphicalrepresentation of a base unit, then there is no need to hide the baseunit in order to provide indication of any of the sensed conditions, theindicia forming the graphical representation of the base unit may beplaced on the display in static form, for example by being preprintedonto the screen surface.

Note that each of FIGS. 9, 18, 19, 20, 21 and 22 are shown with allindicia activated. In operation, the control unit will selectivelydisplay indicia in accordance with the current state of the medicamentdispenser, in order to indicate one or more current sensed conditions ofthe medicament dispenser at any one time. Thus, some indicia will beactivated whilst others are hidden.

Note that, below, the description of elements of each of the screenconfigurations 22 a-f are to be understood to apply to the same iconsand indicia displayed in each of the different screen configurationswhere the same numerical references, incremented by multiples of 100,are used. Although the exact form of the icons and indicia aredifferent, their functions and the control thereof by the control unit90 are similar and therefore should be understood that the descriptionin relation to icons and indicia in one configuration applies equally tosimilarly referenced icons and indicia in different configurations.

Referring now to FIG. 9, the display screen includes a number of iconsand indicia, all of which are separately controllable by the controlunit 90. In this screen configuration, the display includes indicia inthe form of a base unit icon 200, a refill attached icon 202, a doseprimed icon 204, a remove refill icon 206, an attached refill icon 208,a refill unattached icon 210, a dose due icon 212, time elapsed indicia214, dose not due icon 216, dose count indicia 218 and low battery levelicon 219.

As shown in FIG. 9, the base unit icon 200 and the refill attached icon202 are located adjacent one another, and form a representation of theentire medicament dispenser, providing a simplified outlinecorresponding to the external appearance of the medicament dispenser asa whole when the cover 10 has been moved to its dispensing position (seefor example FIGS. 3 a and 3 b). Note that the base unit icon 200 definesa contained area representing an area within the base unit, within whichthe low battery level icon 219 is placed. This aids understanding of thelow battery level condition when generated. Namely, by placing the lowbattery level icon 219 within the contained area defined by the baseunit icon 200, the user can better understand that it is the base unitwhich requires replacement due to the low battery level condition. Theholder 20 is preferably sealed in such a way that the user cannotreadily replace the battery within the base unit. Instead, the user isinstructed to return the base unit and obtain a new base unit whereby tocarry out the remainder of his treatment regimen.

Note further that the display of the refill attached icon 202 isseparately controllable from the display of the base unit icon 200.Thus, by hiding the refill attached icon 202, various different sensedconditions may be indicated to the user in a manner in which theunderstanding of the condition is increased. Such conditions include therefill attached condition, the refill not attached condition, the refillauthenticated condition, the refill invalid condition, the low doseremaining condition and the no dose remaining condition, all of whichmay involve the selected hiding of the refill attached icon, eitherstatically during the indication of the condition, or by alternatelyactivating and hiding the icon to cause the icon to blink, therebyindicating to the user that the condition relates to the refill cassette30. Furthermore, the refill unattached icon 210 which includescomponents similar in form to the refill attached icon, may beselectively controlled to display various conditions, in combinationwith the refill attached icon 202, including the refill attachedcondition (in which case the refill unattached icon 210 can be hidden ina static display), the refill attached condition, the refill invalidcondition, and the no dose remaining condition, in all of which casesthe refill unattached icon 210 may be statically displayed or switchedon and off alternately.

A further graphical representation of the base unit is used in thisembodiment as the dose due icon 212, along with indicia, which form partof the dose due icon 212, indicating the dispensing of medicamenttherefrom, for example in the form of a plume emanating from themouthpiece of the dispenser represented by the icon 212.

The time elapsed indicia 214 consist of a plurality of separatelyactivatable elements, which for example each separately indicated afurther period elapsed since the time of last taking. The dose countindicia 218 consist of a segmented numerical character display, of whichthe individual segments are separately controllable to represent anumber between 0 and 99.

FIGS. 10 to 17 illustrate use of the display configuration illustratedin FIG. 9 to display various conditions sensed by the medicamentdispenser to a user. Note that the display is, under the defaultoperating conditions, not activated, in order to reduce the powerconsumption of the battery within the base unit. However, when the cover10 is opened, the cover open sensor 94 senses the opening of the cover,and in response control unit 90 displays the current operatingconditions of the medicament dispenser on the display 22. Similarly,when a user presses button 24, as sensed by button switch 98, thecontrol unit may activate display 22 to indicate the current operatingconditions of the medicament dispenser. After a preset period ofinactivity by the user, the display may again be powered down.Alternatively, the display may be driven continuously, providingsufficient battery power is provided; this can simplify the electronicsubsystem of the dispenser.

FIG. 10 illustrates the activation of indicia on the display 22 a undernormal operating conditions of the dispenser. In this state, the refillis attached and authenticated, hence refill attached icon 202 isactivated in conjunction with the display of the base unit icon 200. Allother icons in the lower half of the screen are however hidden. Therefill contains 59 doses, hence the dose count indicia 218 areselectively activated to display the numerals “59”. Furthermore, thetime elapsed since last dose taking is five hours, hence five segmentsof the time elapsed indicia are activated and the remainder are hidden.Furthermore, since the time elapsed is within the reminder periodinterval, the dose not due icon 216 is also switched on.

FIG. 11 shows the display 22 a seven hours after the condition shown inFIG. 10. In this state, the time elapsed indicia are all activated,since the time is 12 hours or over since the last dose, and the dose dueicon 212 is activated. Preferably, the dose due icon 212 is alternatelyswitched on and off to highlight to the user that their dose is due.

FIG. 12 illustrates the state of the display 22 a following from thestate indicated in FIG. 11, once the user has primed the index leader ofthe medicament dispenser. Once primed, the dose primed icon 204 isactivated to indicate that the user should now inhale from themouthpiece. The dose primed indicator includes a representation ofpowder located next to the mouthpiece on the refill attached icon 202.

FIG. 13 illustrates the state of the display 22 a once inhalation of themedicament indicator to be available in the display shown in FIG. 12 isperformed by the user. Inhalation of the medicament is detected byinhalation sensor 106, following which the dose primed icon 204 isswitched off, or switched between an alternating display state and astatic display state. Furthermore, the dose not due icon 216, which wasremoved once the time elapsed exceeded the reminder interval isactivated once more, and the time elapsed indicia are switched off toindicate that it is less than one hour since a dose was last taken.Furthermore, the dose count indicia 218 are controlled to decrement thenumerical value shown thereby. Whilst the dose count is reduced here inresponse to the detection of inhalation of the medicament, the dosecount indicia may also be controlled to decrement the numerical valueshown in response to the dose primed condition, since in this state thedose has in fact been dispensed, although not yet inhaled, from therefill cassette 30.

A further possible feature, which is not shown in the display 22 a, isan overexposed dose indicator feature. According to this feature, afterthe dose primed condition, at which point the dose is first exposed tothe atmosphere, a dose exposure period is initiated in the timer of thecontrol unit 90. After a predetermined interval, for example 2 hours, ifthe user has not yet inhaled the dose, as detected by inhalation sensor106, a further set of indicia may be displayed on the display 22 a toindicate that the dose should not be taken by the user, for example byusing a cross-shaped icon over the dose primed icon.

Referring now to FIGS. 14 a and 14 b, after all of the doses availablein the refill cassette 30 are dispensed, the dose count becomes zero, asshown in FIGS. 14 a and 14 b. At this point, the no dose remainingcondition is indicated on the display. In this condition, the dosecounting indicia may be switched on and off alternately. Furthermore,the display state shown in FIG. 14 a may be alternated with the displaystate shown in FIG. 14 b. Thus, the refill attached icon 202 isalternately switched on and off. The removed refill icon 206 isstatically activated, and the refill unattached icon 210 is alternatelyswitched on and off, in counter to the switching on and off of therefill attached icon 202, so that the removal of the refill cassette 30is indicated in an animated display sequence, along with the use of thearrow-shaped icon also indicating such movement to indicate that theempty refill should be removed.

When the empty refill is removed by the user, the refill attached sensor96 generates a refill unattached condition in the control unit 90, whichthen controls the display to show a state as shown in FIG. 15. In thisstate, the dose count indicia are switched off, the refill attached icon202 is hidden, the refill unattached icon 210 is activated, and theattach refill icon 208, in the form of an arrow located between therefill unattached icon 210 and the base unit icon 200 and pointingtowards the base unit 200, is alternately switched on and off toindicate insertion of a new refill cassette 30 into the holder 20.

FIG. 16 illustrates the display state used when a fresh refill,containing 60 doses, is attached to the base unit 200. The display issimilar to that shown in FIG. 10. Note that the time elapsed indicia inthis case are all switched off, since the refill cassette is insertedshortly after the last dose taking by the user. However, in the casethat the refill cassette is replaced some time after the last dosetaking, sufficient to have one or more of the time elapsed indiciadisplayed, the control unit 90 maintains the time elapsed period monitorduring the refill replacement procedure, such that the time elapsedperiod continues to be monitored and indicated without interruptionduring a replacement procedure.

FIGS. 17 a and 17 b illustrate the display state used when the refillinvalid condition is generated by the control unit 90. In this state,the screens shown in FIG. 17 a and that shown in FIG. 17 b arealternately activated. In the state shown in FIG. 17 a, the dose countindicia are altered to show a non-numerical set of characters (forexample EE) and the remove refill sequence, similar to that shown inFIGS. 14 a and 14 b, is used to indicate that the refill should bereplaced with a genuine refill.

FIG. 18 illustrates a further configuration screen display 22 b. In thisconfiguration, the base unit icon 300, the refill attached icon 302, theremove refill icon 306, the attach refill icon 308 and the refillunattached icon 310 have similar configurations and functions ascorresponding elements of the screen display 22 a. The dose due icon312, the time elapsed indicia 314 and the dose not due icon 316 havedifferent configurations but similar functions to that illustrated inFIG. 9. In this case, the dose count indicia 318 are located within alarge refill icon 322, which is a graphical representation of theexternal appearance of at least parts of the refill cassette 30,including its mouthpiece, and within a contained area defined by a largebase unit icon 320. Furthermore, the low battery level icon 319 islocated within a contained area defined by the large base unit 320. Bylocating the dose count indicia 318 within the contained area defined bythe refill icon 322 and/or the base unit icon 320, the understanding ofthe feature that the doses are contained within the refill cassette 30is increased, and the understanding that the battery is located withinthe base unit is also increased, thereby increasing the user'sunderstanding of the functioning of the device. Furthermore, additionaldose due icons 324 are used to indicate that actuation of the indexinglever is required. The icons 324 provide a graphical representation ofthe thumbtab of the index lever adjacent the base unit icon 320, and maybe displayed alternately to indicate movement of the thumbtab of theindex lever, thereby to indicate to the user that the index lever shouldbe primed when a dose is due.

FIG. 19 illustrates a further configuration of a screen display 22 c. Inthis screen display, the configurations of each of the base unit icon400, the refill attached icon 402, the dose primed icon 404, the removerefill icon 406, the attach refill icon 408, the time elapsed indicia414, the dose count indicia 418 and the low battery level icon 419 havedifferent configurations to that shown in FIG. 9, but the functionalityis the same as that described. In this configuration, the dose countindicia 418 are located in a contained area within the refill attachedicon 402, and the battery icon 419 is located within the base unit icon400, to increase conciseness and understandability of the indicationsgiven.

FIG. 20 illustrates an alternative screen display configuration 22 d,similar to that shown in FIG. 19. However, in this case, the base uniticon 500 a, 500 b is split into two separate parts which enclose therefill icon 502. One of the parts, part 500 a, contains the low batterylevel icon 519.

FIG. 21 illustrates a further alternative screen display configuration22 e. In this configuration, all of the base unit icon 600, the refillicon 602, the remove refill icon 616, the attach refill icon 608, therefill unattached icon 610, the time elapsed indicia 614 a, 614 b, thedose count indicia 218 and the low battery level icon 619 are configureddifferently to that shown in FIG. 9, but the functionality is the same.In this embodiment, the dose count indicia 618 are contained within therefill attached icon 602 and the remove refill icon and the attachrefill icon 608 are contained within the refill unattached icon 610, toincrease understandability of the display state within a constrainedarea. Namely, by placing the remove refill icon 606 and the attachrefill icon 608 within the refill unattached icon, the refill unattachedicon 610 may be increased in size without requiring a larger display. Inthis embodiment, the time elapsed indicia are divided into two parts 614a, 614 b, each containing a circular segmented display eachcorresponding to sequential 12 hours periods respectively.

FIG. 22 illustrates a further alternative configuration of displayscreen 22 f. In this configuration, the base unit icon 700, the refillattached icon 702, the remove refill icon 704, the attach refill icon706, the refill unattached icon 710, the time elapsed indicia 714, thedose count indicia 718, the low battery level icon 719, the large baseunit icon 720 and the large refill attached icon 722 have differentconfigurations but have corresponding functions to the similar elementsshown in FIG. 18. Note that the large base unit icon and the largerefill attached icon 722 may be activated and hidden, i.e. switched onand off, in unison with the smaller base unit icon 700 and refillattached icon 702, to increase understanding of the current condition ofthe device to the user.

Note that alternative embodiments to those described above areenvisaged. As an inhalation device, the dispensing outlet is in the formof a mouthpiece through which a user can inhale to access the medicamentin the opened container. However, the medicament dispenser may takeforms of other than an inhalation device, for example a capsuledispenser, a liquid dispenser or a syringe.

The cassette 30 described above includes includes a mouthpiece as adispensing outlet. The dispensing outlet may alternatively have anysuitable form ranging from a simple orifice to a shaped passage (e.g.cone or tube) to a mouthpiece or nozzle.

The medicament carrier may carry medicament in a variety of formsincluding dry powder, granule, aerosol suspension, solution includingaqueous solution, capsule, nebule, pellet and tablet carrier form.

The medicament carrier respectively may itself have a variety of formsother than that described including a capsule; a tablet; an aqueoussolution; an aerosol; and a reservoir carrying multiple doses ofmedicament in a dry powder form or a liquid form.

In the above, the display 22 takes the form of a segmented LCD display.The display may take other forms, for example, comprise a screen such asan LED arrangement or a pixellated LCD display. The display may beembodied using analogue or digital technology.

In the above, detectors are used to sense a condition of the medicamentdetector. Suitably, any actuation detector or release detector comprisesa sensor for detecting any suitable parameter such as movement. Anysuitable sensors are envisaged including the use of optical sensors andelectrical contact switches. The release detector may sense anyparameter affected by release of the medicament such as pressure,temperature, sound, moisture, carbon dioxide concentration and oxygenconcentration.

In the above, the base unit includes a first transceiver fortransmitting and receiving data and in association with the medicamentcarrier, whilst the refill cassette includes a second transceiver fortransmitting and receiving data, wherein data is transferable in two-wayfashion from the first transceiver to the second transceiver. The datais preferably in digital form and suitable for transfer by electronic oroptical means. A medicament dispenser of this general type is describedin pending UK Patent Application No. 0020538.5, the contents of whichare included herein by reference.

In one embodiment herein, a history of the usage of the medicamentdispenser is transferred to the second transceiver. When the blisterstrip in the cassette is exhausted it is exchanged by the patient for anew refill cassette. At the point of exchange, which will typicallyoccur at the pharmacy, data may be transferred from the exhaustedcassette to the refill and vice-versa. Additionally, usage history datamay be read from the refill and transferred to a healthcare datamanagement system for example comprising a network computer system underthe control of a healthcare data manager.

In the above embodiments, the medicament carrier is manually indexed. Inan alternative embodiment, the base unit includes an electronic motor,preferably an ultrasonic motor, for rotating the index wheel 60 and thelid-winding wheel 70 in response to actuation of a switch, for exampleby the user pushing a button.

A medicament dispenser according to the invention is suitable fordispensing medicament, particularly for the treatment of respiratorydisorders such as asthma and chronic obstructive pulmonary disease(COPD).

Appropriate medicaments may thus be selected from, for example,analgesics, e.g., codeine, dihydromorphine, ergotamine, fentanyl ormorphine; anginal preparations, e.g., diltiazem; antiallergics, e.g.,cromoglycate (e.g. s the sodium salt), ketotifen or nedocromil (e.g. asthe sodium salt); antiinfectives e.g., cephalosporins, penicillins,streptomycin, sulphonamides, tetracyclines and pentamidine;antihistamines, e.g., methapyrilene; anti-inflammatories, e.g.,beclomethasone (e.g. as the dipropionate ester), fluticasone (e.g. asthe propionate ester), flunisolide, budesonide, rofleponide, mometasonee.g. as the furoate ester), ciclesonide, triamcinolone (e.g. as theacetonide) or 6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxy-androsta-1,4-diene-17β-carbothioicacid S-(2-oxo-tetrahydro-furan-3-yl) ester; antitussives, e.g.,noscapine; bronchodilators, e.g., albuterol (e.g. as free base orsulphate), salmeterol (e.g. as xinafoate), ephedrine, adrenaline,fenoterol (e.g. as hydrobromide), formoterol (e.g. as fumarate),isoprenaline, metaproterenol, phenylephrine, phenylpropanolamine,pirbuterol (e.g. as acetate), reproterol (e.g. as hydrochloride),rimiterol, terbutaline (e.g. as sulphate), isoetharine, tulobuterol or4-hydroxy-7-[2-[[2-[[3-(2-phenylethoxy)propyl]sulfonyl]ethyl]amino]ethyl-2(3H)-benzothiazolone;adenosine 2 a agonists, e.g.2R,3R,4S,5R)-2-[6-Amino-2-(1S-hydroxymethyl-2-phenyl-ethylamino)-purin-9-yl]-5-(2ethyl-2H-tetrazol-5-yl)-tetrahydro-furan-3,4-diol(e.g. as maleate); α₄ integrin inhibitors e.g.(2S)-3-[4-({[4-(aminocarbonyl)-1-piperidinyl]carbonyl}oxy)phenyl]-2-[((2S)-4-methyl-2-{[2-(2-methylphenoxy)acetyl]amino}pentanoyl) amino] propanoic acid (e.g. as free acid orpotassium salt), diuretics, e.g., amiloride; anticholinergics, e.g.,ipratropium (e.g. as bromide), tiotropium, atropine or oxitropium;hormones, e.g., cortisone, hydrocortisone or prednisolone; xanthines,e.g., aminophylline, choline theophyllinate, lysine theophyllinate ortheophylline; therapeutic proteins and peptides, e.g., insulin orglucagon; vaccines, diagnostics, and gene therapies. It will be clear toa person skilled in the art that, where appropriate, the medicaments maybe used in the form of salts, (e.g., as alkali metal or amine salts oras acid addition salts) or as esters (e.g., lower alkyl esters) or assolvates (e.g., hydrates) to optimise the activity and/or stability ofthe medicament.

Preferred medicaments are selected from albuterol, salmeterol,fluticasone propionate and beclomethasone dipropionate and salts orsolvates thereof, e.g., the sulphate of albuterol and the xinafoate ofsalmeterol.

Medicaments can also be delivered in combinations. Preferredformulations containing combinations of active ingredients containsalbutamol (e.g., as the free base or the sulphate salt) or salmeterol(e.g., as the xinafoate salt) or formoterol (e.g. as the fumarate salt)in combination with an antiinflammatory steroid such as a beclomethasoneester (e.g., the dipropionate) or a fluticasone ester (e.g., thepropionate) or budesonide. A particularly preferred combination is acombination of fluticasone propionate and salmeterol, or a salt thereofparticularly the xinafoate salt). A further combination of particularinterest is budesonide and formoterol (e.g. as the fimarate salt).

Generally, powdered medicament particles suitable for delivery to thebronchial or alveolar region of the lung have an aerodynamic diameter ofless than 10 micrometers, preferably less than 6 micrometers. Othersized particles may be used if delivery to other portions of therespiratory tract is desired, such as the nasal cavity, mouth or throat.The medicament may be delivered as pure drug, but more appropriately, itis preferred that medicaments are delivered together with excipients(carriers) which are suitable for inhalation. Suitable excipientsinclude organic excipients such as polysaccharides (i.e. starch,cellulose and the like), lactose, glucose, mannitol, amino acids, andmaltodextrins, and inorganic excipients such as calcium carbonate orsodium chloride. Lactose is a preferred excipient.

Particles of the powdered medicament and/or excipient may be produced byconventional techniques, for example by micronisation, milling orsieving. Additionally, medicament and/or excipient powders may beengineered with particular densities, size ranges, or characteristics.Particles may comprise active agents, surfactants, wall formingmaterials, or other components considered desirable by those of ordinaryskill.

The excipient may be included with the medicament via well knownmethods, such as by admixing, co-precipitating and the like. Blends ofexcipients and drugs are typically formulated to allow the precisemetering and dispersion of the blend into doses. A standard blend, forexample, contains 13000 micrograms lactose mixed with 50 microgramsdrug, yielding an excipient to drug ratio of 260:1. Dosage blends withexcipient to drug ratios of from 100:1 to 1:1 may be used. At very lowratios of excipient to drug, however, the drug dose reproducibility maybecome more variable.

It will be understood that the present disclosure is for the purpose ofillustration only and the invention extends to modifications, variationsand improvements thereto, and that any elements of the differentembodiments may be combined to form further embodiments of theinvention.

Note that, in other applications of the invention, the base unit, refillcontainer and/or medicament carrier may take a variety of differentforms. Correspondingly, the icons or other graphical representationsused may similarly take a variety of different forms. The invention maybe used for purposes other than informing a taker of medicament; forexample the display functionality may be used for training purposes andfor informing and/or warning caregivers.

The application of which this description and claims form part may beused as a basis for priority in respect of any subsequent application.The claims of such subsequent application may be directed to any featureor combination of features described therein. They may take the form ofproduct, method or use claims and may include, by way of example andwithout limitation, one or more of the appended claims.

1. A medicament dispenser comprising a base unit, the base unit beingadapted for receiving a replaceable refill container and for sensing oneor more conditions of the medicament dispenser, said base unitcomprising display means for displaying indicia representing a state ofthe medicament dispenser, wherein said display means are configured todisplay: first indicia providing a graphical representation of the baseunit; and second indicia providing a graphical representation of arefill container, wherein the display of at least one of said first andsaid second indicia is selectively controllable independently of thedisplay of the other of said first and said second indicia in order toindicate said one or more sensed conditions of the medicament dispenser.2. A medicament dispenser according to claim 1, wherein the base unit isadapted for sensing one or more conditions of the refill container.
 3. Amedicament dispenser according to claim 1, wherein said second indiciaare selectively controllable independently of the display of said firstindicia.
 4. A medicament dispenser according to claim 1, wherein thebase unit is adapted for sensing one or more conditions of the baseunit.
 5. A medicament dispenser according to claim 1, wherein said firstindicia are selectively controllable independently of the display ofsaid second indicia.
 6. A medicament dispenser according to claim 1,wherein said first and said second indicia are displayable together in agraphical representation of the base unit with a refill containerattached thereto.
 7. A medicament dispenser according to claim 1,wherein said base unit includes a mechanical priming component forinitiating the dispensing of medicament and wherein said display meansis configured to display indicia providing a graphical representation ofactuation of the mechanical priming component, the display of themechanical priming indicia being selectively controllable in accordancewith a sensed condition of the mechanical priming component.
 8. Amedicament dispenser according to claim 7, wherein the dispenser isarranged to monitor medicament reminder periods, the display of themechanical priming indicia being selectively controllable in accordancewith a timing condition relating to a medicament reminder period.
 9. Amedicament dispenser according to claim 1, wherein said one or moresensed conditions comprise a medicament quantity condition.
 10. Amedicament dispenser according to claim 9, wherein said display meansare further configured to display indicia representing a medicamentremaining in the form of numeric characters.
 11. A medicament dispenseraccording to claim 10, wherein said refill container contains aplurality of discrete medicaments and said numeric characters representthe number of discrete medicaments remaining.
 12. A medicament dispenseraccording to claim 10, wherein the second indicia define a containedarea representing an area inside the refill container and saidmedicament quantity indicia are located in said contained area.
 13. Amedicament dispenser according to claim 9, wherein said one or moresensed conditions comprise a no medicament remaining condition, or a lowmedicament remaining condition.
 14. A medicament dispenser according toclaim 13, wherein said dispenser is configured, in response to said oneor more sensed conditions, to alternately display and hide said firstand/or said second indicia.
 15. A medicament dispenser according toclaim 1, wherein said display means is configured to display furtherindicia representing removal of the refill container from the base unit.16. A medicament dispenser according to claim 15, wherein said removalindicia comprise indicia in the form of an arrow shape.
 17. A medicamentdispenser according to claim 15, wherein said removal indicia compriseindicia providing a graphical representation of at least part of theexternal appearance of a refill container.
 18. A medicament dispenseraccording to claim 1, wherein said display means are configured todisplay further indicia representing attachment of a refill container tothe base unit.
 19. A medicament dispenser according to claim 18, whereinsaid attachment indicia comprise indicia in the form of an arrow shape.20. A medicament dispenser according to claim 18, wherein saidattachment indicia comprise indicia providing a graphical representationof at least part of the external appearance of a refill container.
 21. Amedicament dispenser according to claim 1, wherein said one or moresensed conditions comprise a condition at to whether or not a refillcontainer is attached.
 22. A medicament dispenser according to claim 1,wherein said one or more sensed conditions comprise a condition as towhether or not which the refill container is validated by the base unitas an authentic refill container.
 23. A medicament dispenser accordingto claim 1, wherein the medicament dispenser is an inhalation device.24. A medicament dispenser according to claim 20, wherein said dispenserincludes a mouthpiece and a sensor for sensing the inhalation ofmedicament through said mouthpiece.
 25. A medicament dispenser accordingto claim 24, wherein said display means are configured to displayindicia representing medicament to be dispensed, and wherein the displayof said indicia representing medicament is selectively controllable inaccordance with an output of said inhalation sensor.
 26. A medicamentdispenser according to claim 1, wherein said one or more sensedconditions comprise a condition in which medication has been dispensedto an output part of the dispenser.
 27. A medicament dispensercomprising a base unit, the base unit being adapted for receiving areplaceable refill container, said base unit comprising a display fordisplaying indicia representing a state of the medicament dispenser,wherein said display means are configured to display: first indiciaproviding a graphical representation of a physical appearance of atleast part of the medicament dispenser; and second indicia representingone or more sensed conditions of the medicament dispenser, wherein saidmedicament dispenser includes a mechanical priming component forinitiating the dispensing of medicament and said second indicia compriseindicia representing actuation of the mechanical priming component. 28.A medicament dispenser according to claim 27, wherein the dispenser isarranged to monitor medicament reminder periods, the display of themechanical priming indicia being selectively controllable in accordancewith a timing condition relating to a medicament reminder period.
 29. Amedicament dispenser according to claim 1, wherein said base unitcomprises: a cover; and a holder, shaped to fit within said body andmovable relative to the cover, wherein said refill container isreceivable by said holder, and wherein movement of the holder relativeto the cover results in movement of the refill container between a firstposition and a second position such that the refill container isreversibly removable from the holder when the refill container is in thesecond position.
 30. A medicament dispenser according to claim 29,wherein medicament is dispensable from said dispenser when the refillcontainer is in the first position.
 31. A medicament dispenser accordingto claim 30, wherein the medicament dispenser is arranged to actuatesaid display means in response to movement of said refill container fromsaid second position to said first position.
 32. A medicament dispenseraccording to claim 1 wherein the medicament is in a form selected fromthe group consisting of capsule; a tablet; an aqueous solution; anaerosol; and a dry powder.
 33. A medicament dispenser according to claim1, wherein the refill container comprises a medicament carriercomprising an elongate strip formed from a base sheet having a pluralityof recesses spaced along its length and a lid sheet peelably sealed insuperposed relationship thereto to define a plurality of blisters, eachfor containing medicament therein.
 34. A medicament dispenser accordingto claim 1, wherein the base unit comprises a first transceiver forreceiving data from a second transceiver located on the refillcontainer.
 35. A medicament dispenser according to claim 1, wherein themedicament is selected from the group consisting of albuterol,salmeterol, fluticasone propionate and beclomethasone dipropionate andsalts or solvates thereof and any combination thereof.
 36. A method ofdispensing medicament comprising the steps of (i) providing of amedicament dispenser according to claim 1 and (ii) dispensing medicamenttherefrom.